Skip to content

Impella RP Flex Introducer Kit 2000342

by Abiomed, Inc. United States GUDID

Product code DYB

Regulatory status

as of 24 Oct 2026

Recall ongoing. 13 ongoing FDA recalls. See recalls

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00813502010411 UDI-DIDate11 Mar 2026ListedStatusIn distribution

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Listed
  • Not covered

United States — GUDID listing Listed

Recalls

13 recalls · 13 ongoing · FDA

  • 13 recalls, same reason

    • Ongoing Z-2687-2026 FDA Class I initiated 11 Jun 2026
    • Ongoing Z-2692-2026 FDA Class I initiated 11 Jun 2026
    • Ongoing Z-2688-2026 FDA Class I initiated 11 Jun 2026
    • Ongoing Z-2685-2026 FDA Class I initiated 11 Jun 2026
    • Ongoing Z-2689-2026 FDA Class I initiated 11 Jun 2026
    • Ongoing Z-2691-2026 FDA Class I initiated 11 Jun 2026
    • Ongoing Z-2682-2026 FDA Class I initiated 11 Jun 2026
    • Ongoing Z-2693-2026 FDA Class I initiated 11 Jun 2026
    • Ongoing Z-2681-2026 FDA Class I initiated 11 Jun 2026
    • Ongoing Z-2684-2026 FDA Class I initiated 11 Jun 2026
    • Ongoing Z-2683-2026 FDA Class I initiated 11 Jun 2026
    • Ongoing Z-2686-2026 FDA Class I initiated 11 Jun 2026
    • Ongoing Z-2690-2026 FDA Class I initiated 11 Jun 2026

    A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set.

Specification

GUDID · synced 22 Oct 2026

Trade Name
Impella RP Flex Introducer Kit
Generic Name
Vascular catheter introduction set, nonimplantable
Model / Reference
2000342
Primary DI / UDI-DI
00813502010411
510(k) Number
FDA Product Code
DYB
GMDN Term
Vascular catheter introduction set, nonimplantable
Device Class
Class II
Regulation Number
870.1340
Commercial Distribution
In Commercial Distribution
MRI Safety
MR Unsafe

Related devices

Cleared under the same submission (K201116)

Other devices from Abiomed, Inc.

See all devices from Abiomed, Inc. →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
  • Single Use
  • Prescription Use
  • Convenience Kit
  • Lot / Batch Number
  • Serial Number
  • Expiration Date
  • Manufacturing Date
Other properties (6)
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No

Sources (1)

  • FDA UDI 9dd6450e-4e03-4010-8633-09957d65fa67 34 fields · synced 22 Oct 2026